Archives for posts with tag: actipatch

Hello Friends,

I recently spoke with the upper management of Bioelectronics Corporation, who as always have been responsive and informative. I rarely call them. Anyway, they are working behind the scenes, be assured of that. Possible partnerships on the horizon, nothing which has not been publicly discussed, but it was good to hear they are still in the game firsthand.

This post is about two items in particular. As the CIA might put it, I have a limited hangout here, nothing earthshattering. However, I want to present some ideas which, if cultivated by a grassroots of #Actipatch supporters, presence on Social Media, in particular Twitter, will be increased significantly.

Two items are pasted below. I will address each in turn. The first, a post on the I-hub Bioelectronic message board about getting more out of Twitter. DewmBoom posts “Tweet for fighting the Opioids Epidemic, Using Actipatch”

DewmBoom, though well-intentioned, should have phrased this thusly:

“Tweet for fighting the #OpioidsEpidemic, Using #Actipatch”

The difference? Hashtags(#) are what demarcate subjects on Twitter. #s are basically the coding signal Twitter uses to categorize “meta” words. I know this from my sub-career as a book promoter. Without the #, you are mainly invisible on Twitter.

https://ritetag.com/best-hashtags-for/backpain I googled twitter pain relief hashatags: Open source, easy access info, and all that is necessary to get a lot more mileage out of Twitter posting is to add two popular hashtags to your post

Screenshot 2017-08-11 at 11.08.15 AM

 

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So, for prospective Twitter users, use #ActiPatch as a central locale on Twitter, but also add another one designed for the topic of the post. Don’t use more than two hashtags, you look like a spammer or a bot.

Case in point. Here is a Tweet from the Bioelectronics Corporation (Actipatch)

It’s a lovely site, a lot going on, but some issues we need to discuss. I will use the post below as an example.

 

Screenshot 2017-08-11 at 10.47.01 AM.png

This post has no hashtags. It uses the word “Paresthesia”, which is from Ancient Greek and basically means that “pins and needles” sensation you get sometimes. Let me play the near perfect score in the verbal section of the SAT card here. If I had to look that up, others had to as well. Problems is you have to get it done in 300 characters. Even #Paresthesia would have been better. Doctors might follow that hashtag.  Also, this is probably about reducing #MenstrualPain using the #Actipatch. Billion dollar industry and I need to say “probably”?

I found this by putting “pins and needles hashtag on Twitter”into Google search

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found this by putting “paresthesia hashtag on Twitter” into Google search. They are out there, but we need to start adding hashtag to the best metawords in the post.

I promised there would be nothing earthshattering, didn’t I?

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People love this product, and there is a lot of interest in reducing opioid addiction, helping people relieve pain safely, and being truly socially responsible. Incrementally, with baby steps, we could get this boulder rolling downhill and let it assume a life of its own through social media.

So whats the first step? At least start using #Actipatch. This will help organize people on Twitter. After that, the best hashtags will reveal themselves. I have been tweeting President Trump and even First Lady Melania whenever either tweets about the opioid crisis, which apparently started the day Trump was inaugurated, testing it. Like, retweet, reply #Actipatch. I will follow anyone who uses #Actipatch in a Tweet, and so should everyone else.

frodo

 

I pasted some new development about Bioelectronics below. The post is from the company by way of srinsocal from the I-hub message board. I italicized and bracketed their comment with parenthesizes.

The marathon continues.

One positive takeaway is the FDA has agreed to review data already submitted for the 510K for musculoskeletal pain, especially back pain. This possibly indicates some forth coming closure on the back pain application since it would indicate the submission is complete.

This stock needs a win, and it would be very good to get FDA approval for at least one application, as all else would logically follow even if more data is required for the other ones, specifically knee and plantar fascitis.

BIEL’s management was smart to engage lawyers to help navigate this thing. Maybe that will make a difference this time. There are only so many ways you can crunch numbers, and the FDA must be great at this, so for back pain at least, we may expect closure in a reasonable time, or at least I can’t see why we wouldn’t. I bought more.

 

POST

“Pending U.S. FDA Market Clearance for Over-the-Counter Sales

We had a second status meeting with the FDA on Wednesday, July 20, 2016. Senior Management from the Neurology and Physical Medicine Group, 4 examiners, the Head of the Physical Medicine, and the project statistician were present. The meeting went well and the tenor was very good.

Senior Management once again attended meeting showing that this is still an important priority project for the FDA

They have accepted our knee and plantar fasciitis studies as indicative of musculoskeletal pain relief and our explanation of our unique mechanism of action.

(Bingo!, Knee and Plantar Fasciitis are FDA acceptable and Mechanism of Action is no longer an issue.)

However, they would like a third study to substantiate our broader indication of use. To accommodate our request for market clearance for the relief of musculoskeletal pain, the examiners have agreed to exclusively review the back pain data from our UK Registry studies. Some of this data is peer reviewed and published. We have approximately 4,500 subject’s responses, who used the trial device for musculoskeletal back pain, as well as data on over 100 subjects demonstrating the durability of therapy over a 6 month study period for back pain.”

 

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My open letter to the new FDA Commissioner:

Dear Robert M. Califf, MD,

Congratulations on your new role as FDA Commissioner. I wish you every success in your endeavor to safeguard the populace against dangerous and ineffective drugs.

Having said this, let me point out that your predecessor, Dr. Margaret Hamburg, was (allegedly) not as rigorously ethical as might be hoped. Please see the excerpt below. I have underlined some pertinent lines.

Excerpt:

“… Hamburg also came under fire when she approved the highly addictive painkiller drug, Zogenix
In December 2012, an FDA advisory panel of experts voted 11 to 2 against approval of the painkiller, Zohydro ER. The panel cited concerns over that drug’s potential for overdose. Indeed, 28 law enforcement agencies and addiction experts had voiced concern that approval of a pure hydrocodone drug will lead to an increase in overdoses and deaths. Zogenix, could be used by people addicted to other opioids, including oxycodone.

Fifteen anti-addiction groups wrote a letter of complaint to the Secretary of Health and Human Services. Despite the safety concerns by the medical and law enforcement community, and despite the expert panel’s overwhelming rejection of the drug, Dr. Hamburg approved it.

The lawsuit provides documentation showing that from 2011 to May 2015, Dr. Hamburg’s husband’s hedge fund, Renaissance Technologies, “not coincidentally, held stock in Alkermes, the manufacturer of Zohydro amounting to tens of millions of dollars. Does anyone not recognize corruption?

The conflict of interest doesn’t end there. Adding even more insult to injury, Alkermes also manufactures a drug to TREAT addiction. So, both Alkermes and Renaissance Tech were given the FDA green light to rake in profits from both the sale of a highly addictive drug, then cashing in on the sale of a treatment for that drug-induced addiction!!…”

http://ahrp.org/former-fda-commissioner-charged-in-federal-racketeering-lawsuit/

My point in posting sending you this is in no way to exhibit Schadenfreude at the Doctor Hamburg’s downfall. I think it is tragic such a talented person could have such egregiously misplaced priorities. Still, it does beg the question—could Doctor Hamburg have been  purposely sabotaging the approval of a device which could curtail the use of drugs to treat addiction, and even lower the rates of addiction!! One shudders at the thought, but have we really unearthed the depths of what the completely avaricious and selfish personality type is capable of?

So, I submit this as food for thought. I admit you don’t know me from Adam and compared to someone such as yourself, I am a mere dabbler in science, though I do make a living at it, such as it is, and have a graduate degree in Biochemistry. However, I think this email, if viewed objectively, should at least be considered as grounds for examining 510(k) file number K152432, and hopefully facilitating the approval of this drug free pain relief technology to the masses.

This technology is available in 50+ countries OTC, but not the USA. The graphic pasted below depicts results from a study published in the Journal of Rheumatology using this technology-link: http://rheumatology.oxfordjournals.org/content/early/2015/12/23/rheumatology.kev426.long

I leave you with a final thought: Someday, it will be considered barbaric that we drugged the whole body to treat the pain of one particular part.

Be well, and God bless,

PJ Kelley.

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The Oxford journal Rheumatology published the results of a study conducted to measure how effective the Bioelectronics Company’s Actipatch was in treating chronic osteoarthritis pain in the human knee today. The date says December 24th was the online publishing date. This may have been for subscribers. Bioelectronics announced it today, but the results have been known, mainly, for a while. The significance of this is a reputable, peer reviewed journal published the results in a nice layout with charts and references. This paper was already mainly priced in to the stock.

The study compared two groups, those who used the Actipatch (a device which uses PEMF (pulsed electromagnetic fields) to a placebo using group. They monitored a couple of tests, such as quality of life and increase or decrease of “NSAIDS” (non steroidal anti-inflammatory drugs).

The paper can be found here.

The results were quite stunning, really, though I say this without access to the raw data tables. I like to crunch my own numbers.

Roughly, 20% improvement in pain relief for Patch users, 2 to 3 % improvement for Placebo. The chart below tells the tale.

Fig. 2

Also gauged was the use of NSAIDS in the Actipatch versus Placebo groups. This is important, so this is what I am focusing on, since this is where this study could possibly use some improvement. I pasted Table 3 from the paper at the bottom for illustration.

I read this table as stating at the end of a month, 46% of Patch users were using NSAIDS/analgesics as opposed to 90% of placebo users. So far so good, and the Patch could be approved by the FDA on the strength of this alone.  The FDA has approved on less, statistically.

However, the second part of the table could have been interpreted better in the footnote.

10% of placebo group started using NSAIDS/analgesics, while 0% of Patch users started taking drugs after a month.

However, if you were using drugs and had the Patch, it looks like 26% stopped using, while 23% of placebo users stopped. This is not very statistically significant. I get 23% by subtracting 3 from 10 and dividing by 30. So only 7 of the Placebo users actually stopped taking drugs. This is a statistical tie, and this is the part of the study I think could be fine tuned.

Liver and kidney damage combined with drug addiction is lethal, and there is a real need for a treatment which decreases these, especially in combination.

From the paper:

“Another interesting aspect of the interaction between electromagnetic fields and pain is related to opioid function; it has been demonstrated in mice that the induction of analgesia by electromagnetic exposure was equivalent to a moderate dose of morphine [32]. ”

So, instead of a study which treats drug use in a Boolean way (that is, you are either using pain killer drugs or not), there needs to be a study for tapering off using the Patch versus the placebo. If people use lower doses of drugs, odds of addiction, kidney, and liver damage are decreased. A primary benefit of the Actipatch is it will help people lower the dose. They might still be taking NSAIDS/analgesic drugs, but will just require less of them.

The patients in this study using the Patch and NSAIDS/analgesics (fully prescribed amounts) might have been been able to use a lower dose, but the study does not capture this.

I do not want to seem like a negative Nelly. The study was tremendous. I am simply pointing out that big selling point of the Patch is underexplored here. This is a not a comment on the pending FDA approval, which should occur, rather an observation about the study. Dr. Bagnato talks about further studies going directly against pain drugs with the Patch. “Tapering off” Placebo versus Actipatch, should be a part of this study.

*This blog concerns itself with topics including drug trafficking throughout the world.

How many people have you personally known who have died of terrorism as opposed to people who have overdosed, either dying or sustaining liver, kidney, or addiction problems? The magnitude of the problem is huge, and the Drug War is used as an excuse to take away our civil liberties and perpetrate a flawed foreign policy. Americans are not the only victims of the Drug War. Whether coincidentally or not, USA government policy works in a contradictory fashion. The Taliban had eliminated poppy cultivation in Afghanistan, but the USA and Britain opened that market back up again. A lot of people are dying from heroin addiction, and it is Satanic, not a word I use lightly.

A lot of people get hooked, innocently enough, by our own Medical establishment, which is terminally ignorant, seemingly, of the nature of the addictive personality. The end results is people move from prescribed drugs to street drugs, a self-fueling prophecy.

There used to be a blogger who got shut down who said the Queen of England regarded heroin addicts as annuities. Certainly, every President of the USA has been related to her, including Obama on the American side. The FDA needs to approve alternative remedies to drugs. The Patch has no side effects of note, but drugs are killing people. The benefits of FDA approval for the Actipatch outweigh the minimal risk.

**Check links for free books (periodically).

 

Table 3

Changes in intake of NSAIDs/analgesics

NSAID/analgesic intake PEMF (n = 30) Placebo (n = 30)
Subject’s daily drug intake at 1 months
    NSAIDs, n (%) 6 (20) 12 (40)
    Analgesics, n (%) 8 (26) 15 (50)
Changes in drug intake at 1 month follow-up
    Started NSAIDs/ analgesics, n (%) – (0) 3 (10)
    Stopped NSAIDs/ analgesics, n (%) 8 (26) 10 (33)
  • At the end of the trial, 46% subjects from the PEMF group and 90% patients from the placebo group were under treatment with NSAIDs/analgesics. In the PEMF group, 26% (n = 8) stopped the pharmacological therapy compared with baseline, whereas in the placebo group 10% (n = 3) started a new therapy with NSAIDs/analgesics and one patient stopped previous treatment. PEMF: pulsed electromagnetic fields.